PMA P180002S026
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S026
- Product code
- NJK
- Decision date
- 2024-03-01
- Classification
- Anesthesiology
- Generic name
- Valve, pulmonary
- Approval order statement
- Manufacturing change allowing option to perform two sterilization cycles on the Zephyr Endobronchial Delivery Catheters.
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S026
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2024-03-01
- Decision code
- OK30
- Date received
- 2024-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change allowing option to perform two sterilization cycles on the Zephyr Endobronchial Delivery Catheters.